Efficacy and Safety of Liraglutide in Type 2 Diabetes With Lower Extremity Arterial Disease

What Was Tested

In this phase 4 trial, researchers set out to test Liraglutide.

Diabetic lower extremity arterial disease ( DLEAD ), is a common complication of type 2 diabetes.

It had two arms (groups): Liraglutide+standard-of-care treatment (experimental) and standard-of-care treatment (active comparator).

Intervention: Liraglutide is added to existing standard-of-care treatment containing one or more oral anti-hyperglycemic agents or insulin or a combination of these agents with the exception of other incretin and SGLT2i therapies.

Standard-of-care treatment with the exception of incretin and SGLT2i therapies. This approach expect to yield similar glycemic control in the two study groups.

The registry classes the interventions as drug and other.

More on the Plan

Eligible patients will be randomized 1:1 to with or without liraglutide treatment by a 6-month follow-up.

The primary endpoints are the change in initial and absolute claudication distance and assessment of limb ischemia at 6 months compared with baseline.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 40 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Type 2 diabetes (1999 WHO criteria). Age \> 40 years. Lower extremity PAD with symptom. Absence of distal arterial pulse. Presence of stenosis or occlusion of lower extremity arteries as determined by Duplex ultrasound imaging or lower extremity CTA; or lower extremity DSA(Digital Substraction Angiography).

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: type 1 diabetes; other concomitant illness:; recent (within 6 months) surgery or trauma.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Liraglutide was given.

Those kept unaware of assignments: participant.

It started in 2020-05-01 with completion listed for 2021-12-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Initial and absolute claudication distance (time frame: 24 weeks).

It also tracked 5 secondary outcomes, for example Assess the effects on ABI of a six month treatment with Liraglutide compared to control group (standard-of-care treatment), Muscle microvascular perfusion by CEU and Changes from baseline in HbA1c.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.